What additional medication would be beneficial for a 60-year-old female with Type 2 diabetes (T2D) and hyperlipidemia, with an elevated Hemoglobin A1c (HbA1c) level, currently adhering to Trulicity (dulaglutide) injection, and having previously not tolerated metformin?

From the Guidelines

For this 60-year-old female with poorly controlled Type 2 diabetes (HbA1c 11.4%) who is currently only on Trulicity and cannot tolerate metformin, I recommend adding an SGLT-2 inhibitor such as empagliflozin (Jardiance) 10mg daily or dapagliflozin (Farxiga) 5mg daily. These medications would complement her GLP-1 receptor agonist (Trulicity) therapy by working through a different mechanism - reducing glucose reabsorption in the kidneys, promoting urinary glucose excretion, and providing modest weight loss. SGLT-2 inhibitors offer additional cardiovascular and renal protective benefits, which is particularly important given her age and comorbid hyperlipidemia, as supported by the 2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD 1. This combination therapy approach is likely to significantly improve her glycemic control, as her current HbA1c of 11.4% indicates her diabetes is severely uncontrolled despite Trulicity. Key benefits of this approach include:

• Improved glycemic control
• Cardiovascular protection
• Renal protection
• Modest weight loss If contraindications to SGLT-2 inhibitors exist, a DPP-4 inhibitor like sitagliptin (Januvia) 100mg daily could be considered, though it would provide less robust glucose-lowering effects, and its use should be cautious in patients with high risk of heart failure, as noted in the 2019 ESC guidelines 1. Regular monitoring of kidney function and for genital mycotic infections would be necessary with SGLT-2 inhibitor therapy. The stepwise addition of glucose-lowering medication is generally preferred to initial combination therapy, as recommended by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in their 2018 consensus report 1. However, given the patient's severely uncontrolled diabetes, the addition of an SGLT-2 inhibitor to her current Trulicity regimen is a reasonable and evidence-based approach to achieve better glycemic control and reduce cardiovascular risk.

From the FDA Drug Label

JARDIANCE used in combination with insulin (with or without metformin and/or sulfonylurea) provided statistically significant reductions in HbA1c and FPG compared to placebo after both 18 and 78 weeks of treatment JARDIANCE 10 mg or 25 mg daily also resulted in statistically significantly greater percent body weight reduction compared to placebo A total of 498 patients with type 2 diabetes participated in a double-blind, placebo-controlled study to evaluate the efficacy and safety of JARDIANCE in combination with pioglitazone, with or without metformin Treatment with JARDIANCE 10 mg or 25 mg daily resulted in statistically significant reductions in HbA1c (p-value <0. 0001), FPG, and body weight compared with placebo

The patient is currently on Trulicity injection and has a history of not tolerating metformin. Empagliflozin (JARDIANCE) could be a beneficial medication for this patient as it has been shown to provide statistically significant reductions in HbA1c and FPG when used in combination with other medications, including insulin and pioglitazone. Additionally, it has been shown to result in statistically significant reductions in body weight. However, the patient's renal function should be considered before initiating empagliflozin, as its efficacy decreases with decreasing renal function 2, 2.

• Key benefits of empagliflozin:
  • Statistically significant reductions in HbA1c and FPG
  • Statistically significant reductions in body weight
  • Can be used in combination with other medications, including insulin and pioglitazone
• Important consideration:
  • Renal function should be considered before initiating empagliflozin, as its efficacy decreases with decreasing renal function

From the Research

Patient Profile

• 60-year-old female with a history of Type 2 diabetes and hyperlipidemia
• Last HA1c: 11.4
• Current medication: Trulicity injection
• Patient reports adherence to the current regimen
• Did not tolerate metformin in the past

Potential Medication Options

• Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to improve glycemic control, promote weight loss, and reduce blood pressure in patients with Type 2 diabetes 3, 4
• Empagliflozin has been found to be well-tolerated, with a low incidence of hypoglycemia, and can be administered orally 3
• Studies have demonstrated the efficacy of empagliflozin as an add-on to metformin or as a monotherapy in patients with Type 2 diabetes 3, 4

Considerations

• The patient's history of not tolerating metformin suggests that an alternative medication, such as empagliflozin, may be a suitable option
• Empagliflozin's mechanism of action, which promotes urinary glucose excretion, may be beneficial for patients with Type 2 diabetes who have difficulty achieving glycemic control with other medications 3, 5
• The patient's profile, including her age and medical history, should be taken into consideration when selecting a medication, and a comprehensive patient history should be taken to inform diagnosis and treatment 6